미국의 심부전 POC 및 LOC 기기 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the united states heart failure POC and LOC devices market size is projected to expand from USD 75.29 million in 2025 and USD 84.02 million in 2026 to USD 152.97 million by 2031, registering a CAGR of 12.73% between 2026 to 2031.

This report is Segmented by Device Type (POC, LOC), Test Type (Proteomic, Metabolomic, Genomic), Technology (Microfluidics, Array-Based), Biomarker (NT-proBNP/BNP, Troponin, Multi-Biomarker Panels), Application (Acute HF, Chronic HF Monitoring, Risk Stratification), and End User (Hospitals, Specialty Centers, and More). The Market Forecasts are Provided in Terms of Value (USD).

United States Heart Failure POC and LOC Devices Market Trends and Insights

Expanding Medicare Coverage for Near-Patient Natriuretic Peptide Testing

Medicare's revised LCD L34410, effective February 15, 2026, combines Part A and Part B coverage for BNP and NT-proBNP into one clearer framework for acute dyspnea evaluation, severity assessment, and risk stratification in emergency and outpatient settings. That change matters for the heart failure POC and LOC devices market because it reduces billing ambiguity for providers that operate across hospital and outpatient sites under the same health system structure. The CMS raised reimbursement for near-patient BNP testing to USD 24 per test and removed prior authorization requirements for Medicare Advantage plans, which improves the revenue case for physician offices and urgent care use. The direct beneficiary is the CLIA-waived whole blood BNP format because it avoids plasma preparation and lowers staffing needs at lower-acuity sites, a profile that aligns with the QuidelOrtho Triage BNP Test. This is especially relevant for the large physician office-based in the United States, where clinical demand existed before, but reimbursement clarity had remained inconsistent across settings. The result is a sharper commercial path for decentralized testing sites that need fast cardiac rule-in and rule-out support without a full laboratory buildout.

CLIA-Waived Decentralization of BNP Assays in Physician Offices and Urgent Care

The FDA's waived test list shows that selected BNP platforms obtained CLIA-waived status, which changed the staffing and deployment economics for natriuretic peptide testing outside traditional laboratories. That development supports the heart failure POC and LOC devices market because it allows testing in physician offices, urgent care centers, and retail-linked care sites that cannot support higher-complexity operations. The practical impact is that primary care physicians can receive BNP results during the visit instead of sending patients into a slower referral pathway before treatment decisions begin. The fingerstick BNP and NT-proBNP workflows in retail and community settings create a channel outside hospital procurement and widen access points for earlier evaluation. A 2026 ICare-FASTER preprint described analytical advances that support very small capillary sample volumes, which is important because small sample requirements make decentralized fingerstick workflows more realistic at scale. The waiver framework, therefore, does more than simplify compliance; it also shapes product design priorities by rewarding devices that keep performance high while making the operating process simpler.

Moderate-Complexity Classification Limits Broad Decentralized Deployment

CLIA waiver has helped some BNP formats, but many of the strongest-performing NT-proBNP assays still remain outside waived status and require higher oversight before they can be used in decentralized care settings. This creates a practical mismatch in the heart failure POC and LOC devices market because the sites with the biggest access gaps are often the same sites that lack moderate-complexity infrastructure. 75% of U.S. urgent care centers do not have the certification framework needed to run these assays without additional staffing and compliance investment, which directly limits adoption beyond hospital-linked networks. That barrier is more manageable for hospital-owned urgent care sites because they already operate within existing quality systems and oversight arrangements. Independent chains and community providers face a harder choice because they must either upgrade certification or accept lower-performance testing options. The result is a slower move toward broad decentralization than the analytical performance of the devices alone would suggest.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Need to Reduce Emergency Department Length of Stay Through Rapid Triage
2. Adoption of Connected Multi-Marker Panels for Earlier Heart Failure Risk Stratification
3. Reimbursement Friction for Multi-Test Cartridges and Advanced Panel Bundles

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Point-of-Care devices held 64.23% of the heart failure POC and LOC devices market share in 2025, which reflects their long-established role in emergency departments and acute care workflows, where BNP and troponin testing already fit validated reimbursement and protocol structures. These systems remain difficult to displace because hospitals have already invested in analyzers, reagent agreements, staff training, and EHR connectivity that are tied to routine cardiac testing. Siemens, QuidelOrtho, and Radiometer benefit from this installed base effect because device replacement requires operational change rather than just a product swap. In practice, the point-of-care segment still dominates higher-acuity settings where speed, familiarity, and audit-ready workflows matter more than full miniaturization. The device type mix, therefore, reflects both clinical performance and the cost of changing existing hospital operations within the heart failure POC and LOC devices industry.

Lab-on-Chip devices are projected to expand at a 13.25% CAGR through 2031, which makes them the fastest-growing device class in the heart failure POC and LOC devices market. Their main advantage is not immediate displacement of hospital analyzers, but entry into physician offices, urgent care, discharge follow-up, and home-linked monitoring pathways where legacy systems have a weaker reach. Nature's 2026 study on dual-mode multiplexed optical sensing showed how miniaturized platforms are moving toward very high analytical sensitivity in compact formats, which supports the credibility of LOC expansion. Abbott's i-STAT Alinity cartridge and Siemens' Atellica VTLi show how commercial products are already closing the gap between compact design and clinically acceptable turnaround time. As performance parity improves, LOC devices are more likely to win incremental demand in greenfield settings first and then compete more directly in emergency care later in the forecast period.

Proteomic testing accounted for 51.23% of test-type revenue in 2025, which made it the largest test segment in the heart failure POC and LOC devices market size because BNP, NT-proBNP, and troponin assays already have clinical precedent, reimbursement pathways, and broad analyzer compatibility. This segment remains the revenue anchor because hospitals, payers, and accreditation bodies are more comfortable with assays that already carry established thresholds and long clinical use histories. FDA-cleared proteomic assays are especially valuable in clinical operations because they support defensible documentation during audit, utilization review, and treatment escalation decisions. The depth of outcome evidence behind natriuretic peptides also keeps this segment central even as new test formats arrive. For these reasons, proteomics is likely to remain the commercial core of the heart failure POC and LOC devices industry through the medium term.

Metabolomic testing is projected to grow at a 15.97% CAGR through 2031, making it the fastest-growing test category in the heart failure POC and LOC devices market. Scientific Reports in 2025 showed that plasma metabolic signatures can differentiate heart failure phenotypes with high model accuracy, which gives this segment a clearer clinical role than it had only a few years ago. The International Journal of Molecular Sciences also linked ADMA, TMAO, and acylcarnitines to HFpEF in hypertensive patients, which is especially relevant because HFpEF has lacked a simple confirmatory point-of-care marker. That makes metabolomics valuable not only for diagnosis, but also for subtype refinement and therapy response tracking, where conventional natriuretic peptides may not be enough on their own. Genomic testing remains more limited and is still largely concentrated in academic settings, so its commercial contribution is expected to stay small relative to proteomic and metabolomic formats through 2031.

Complete Report Scope:

• By Device Type
  • Point-of-Care Devices
  • Lab-on-Chip Devices
• By Test Type
  • Proteomic Testing
  • Metabolomic Testing
  • Genomic Testing
• By Technology
  • Microfluidics
  • Array-Based Systems
• By Biomarker
  • NT-proBNP and BNP
  • Troponin
  • Multi-Biomarker Panels
• By Application
  • Acute Heart Failure Diagnosis in Emergency Settings
  • Chronic Heart Failure Monitoring and Therapy Optimization
  • Risk Stratification and Readmission Prevention
• By End User
  • Hospitals and Clinics
  • Specialty Centers
  • Homecare and Remote Patient Monitoring Programs
  • Primary Care and Urgent Care Centers

List of Companies Covered in this Report:

1. Abbott Laboratories
2. Beckton Dickinson
3. Beckton Dickinson
4. Bio-Rad Laboratories
5. bioMerieux S.A.
6. BIOTRONIK
7. Boston Scientific
8. Cardinal Health
9. Cleveland HeartLab, Inc.
10. Danaher
11. GE HealthCare Technologies Inc.
12. LivaNova
13. Medtronic
14. Nova Biomedical
15. Philips N.V.
16. QuidelOrtho
17. Radiometer Medical ApS
18. Roche
19. Siemens Healthineers
20. Trinity Biotech plc

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Expanding Medicare Coverage for Near-Patient Natriuretic Peptide Testing
  • 4.2.2 CLIA-Waived Decentralization of BNP Assays in Physician Offices and Urgent Care
  • 4.2.3 Rising Need to Reduce Emergency Department Length of Stay Through Rapid Triage
  • 4.2.4 Adoption of Connected Multi-Marker Panels for Earlier Heart Failure Risk Stratification
  • 4.2.5 AI-Enabled Interpretation of BNP, NT-proBNP, and Cardiac Biomarker Outputs
  • 4.2.6 Fingerstick-Compatible Microfluidic Platforms Extending Testing Beyond Traditional Labs
• 4.3 Market Restraints
  • 4.3.1 Moderate-Complexity Classification Limits Broad Decentralized Deployment
  • 4.3.2 Reimbursement Friction for Multi-Test Cartridges and Advanced Panel Bundles
  • 4.3.3 High Clinical Validation Burden for Novel LOC Biomarker Combinations
  • 4.3.4 Installed Base Resistance From Central Laboratory Workflow Preferences
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Device Type
  • 5.1.1 Point-of-Care Devices
  • 5.1.2 Lab-on-Chip Devices
• 5.2 By Test Type
  • 5.2.1 Proteomic Testing
  • 5.2.2 Metabolomic Testing
  • 5.2.3 Genomic Testing
• 5.3 By Technology
  • 5.3.1 Microfluidics
  • 5.3.2 Array-Based Systems
• 5.4 By Biomarker
  • 5.4.1 NT-proBNP and BNP
  • 5.4.2 Troponin
  • 5.4.3 Multi-Biomarker Panels
• 5.5 By Application
  • 5.5.1 Acute Heart Failure Diagnosis in Emergency Settings
  • 5.5.2 Chronic Heart Failure Monitoring and Therapy Optimization
  • 5.5.3 Risk Stratification and Readmission Prevention
• 5.6 By End User
  • 5.6.1 Hospitals and Clinics
  • 5.6.2 Specialty Centers
  • 5.6.3 Homecare and Remote Patient Monitoring Programs
  • 5.6.4 Primary Care and Urgent Care Centers

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Beckman Coulter, Inc.
  • 6.3.3 Becton, Dickinson and Company
  • 6.3.4 Bio-Rad Laboratories, Inc.
  • 6.3.5 bioMerieux S.A.
  • 6.3.6 Biotronik SE and Co. KG
  • 6.3.7 Boston Scientific Corporation
  • 6.3.8 Cardinal Health, Inc.
  • 6.3.9 Cleveland HeartLab, Inc.
  • 6.3.10 Danaher Corporation
  • 6.3.11 GE HealthCare Technologies Inc.
  • 6.3.12 LivaNova PLC
  • 6.3.13 Medtronic plc
  • 6.3.14 Nova Biomedical Corporation
  • 6.3.15 Philips N.V.
  • 6.3.16 QuidelOrtho Corporation
  • 6.3.17 Radiometer Medical ApS
  • 6.3.18 Roche Diagnostics
  • 6.3.19 Siemens Healthineers AG
  • 6.3.20 Trinity Biotech plc

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment